Senior Assistant Pharmacy Quality Assurance

7 months ago

Truro, United Kingdom Royal Cornwall Hospitals NHS Trust Full time

An exciting opportunity to join the Quality Assurance team working in Pharmacy Technical Services Unit (PTSU) at the Royal Cornwall Hospital. We are looking to recruit an enthusiastic, motivated individual who can support the Quality Management System, routinely processing and monitoring on data gathered through drug storage monitoring.

The PTSU is a large, dedicated facility producing chemotherapy, TPN and a range of other aseptic products under section 10 exemption, and radiopharmaceuticals and non-sterile manufacture under an MHRA Specials license, with the possibility of extending this license to other products and services. The PTSU currently produces approximately 2,000 aseptic items a month and 6,500 non-sterile items. The supply service is licensed by the MHRA as a wholesaler.

This is a good opportunity to adopt the perfect work/life balance taking advantage of the surrounding countryside and beaches

To work as a member of a Pharmacy Quality Assurance team to support the Quality Management System.

The QA team manages drug storage monitoring throughout the Trust and this role is a key element of that provision; managing temperature data loggers, fault finding/rectification and reporting findings to key staff outside Pharmacy. This post will be responsible for logger programming, validation mapping and report writing for drug storage areas and management of the community temperature loggers.

The role also includes the processing of QC data, the preparation & maintenance of the quality assurance documentation system for the RCHT Pharmacy department and assisting in internal auditing of the quality assurance system. Being a member of the QA team, the job holder will take part in project and validation work.

Working on a routine basis from the Pharmacy Technical Services Unit, where work in clean rooms and QA laboratory performing physical, chemical and microbiological testing, may also be involved

Clean room monitoring includes particle counting, cytotoxic residue testing and active microbiological sampling. Process and report on the data gathered from testing

Royal Cornwall Hospitals NHS Trust is the biggest provider of healthcare services in Cornwall and the Isles of Scilly. Our three main sites are Royal Cornwall Hospital Truro, St Michael’s Hospital Hayle and West Cornwall Hospital Penzance, our staff and services are available across the region.

The Trust employs 5,000+ staff, has a budget of £380 million and 750 beds. We work with health and social care organisations -including NHS Kernow and NHS England
- to ensure local healthcare needs are met. We provide acute medical, surgical and specialist services to around 500,000- which can increase significantly during busy holiday periods.

The Trust has teaching hospitals status as part of the University of Exeter Medical School. Keeping at the forefront of medical advances, we continually develop clinical services and are committed to maximising the range of specialist care offered locally.

We can offer you a rewarding career in a supportive working environment. We have extensive educational links to help you realise your full potential and develop skills to provide outstanding healthcare to the local community.

Enjoy an outstanding quality of life in a place that offers surfing beaches and fishing harbours to beautiful countryside and historic towns. With clean air, plenty of opportunities for outdoor activities and excellent schools, colleges and universities (including adult education) it is the ideal place for families and for you to develop your own career.

**Main responsibilities include**:
To read / record / process thermometer & data logging equipment results

To program loggers with the correct compliance limits, sample frequencies and locations

To calculate data for the ‘hot storage area’ report

To scope storage areas and develop validation mapping plans, download data and create the mapping report for each area including the identification any change to monitoring points.

To download and process data logger information.

Produce data logger reports.

To perform cytotoxic residue testing

To input data from microbiological tests and produce reports

To perform monthly monitoring on clean rooms and process data

Audit data input to check for accuracy

To check incoming QC data for compliance with standards

To raise non-conformities, input & track progress through database where results deviate from required limits

Modify documents in accordance with author changes.

Modify document control issue numbers.

Ensure that controlled copies of documents are created (and withdrawn) and placed in all of the relevant locations.

Ensure document change control process is up to date.

Assist with audits.

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